INDOCIN I.V. is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray.

FOR INTRAVENOUS ADMINISTRATION ONLY.

Dosage recommendations for closure of the ductus arteriosus depend on the age of the infant at the time of therapy. A course of therapy is defined as three intravenous doses of INDOCIN I.V. given at 12-24 hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output < 0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of INDOCIN I.V., no additional doses should be given until laboratory studies indicate that renal function has returned to normal (see WARNINGS, Renal Effects).

Dosage according to age is as follows:

If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of INDOCIN I.V., no further doses are necessary. If the ductus arteriosus re-opens, a second course of 1-3 doses may be given, each dose separated by a 12-24 hour interval as described above.

If the neonate remains unresponsive to therapy with INDOCIN I.V. after 2 courses, surgery may be necessary for closure of the ductus arteriosus. If severe adverse reactions occur, STOP THE DRUG.

Directions For Use

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The reconstituted solution is clear, slightly yellow and essentially free from visible particles.

The solution should be prepared only with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, all diluents should be preservative-free. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Any unused portion of the solution should be discarded because there is no preservative contained in the vial. A fresh solution should be prepared just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20-30 minutes.

INDOCIN I.V. is not buffered. Further dilution with intravenous infusion solutions is not recommended.

Sterile INDOCIN I.V. is a lyophilized white to yellow powder or plug supplied as single dose vials containing indomethacin for injection, equivalent to 1 mg indomethacin.

NDC 67386-511-51.

Storage

Store below 30°C (86°F). Protect from light. Store container in carton until contents have been used.

Manufactured by Merck & Co. Inc., Whitehouse Station, NJ 08889, U.S.A. for: OVATION Pharmaceuticals. Revised July 2006. FDA Rev date: 1/30/2007

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